SUGAR FREE GERI-MUCIL- psyllium powder, for solution 
GERI-CARE PHARMACEUTICAL CORP

Disclaimer: Most OTC drugs are not reviewed and approved by FDA, however they may be marketed if they comply with applicable regulations and policies. FDA has not evaluated whether this product complies.

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GC 481-01

Active ingredient (in each rounded teaspoon)

Psyllium Powder, approximately 3.4 g

Purpose

Fiber laxative

Uses

  • effective in treating occasional constipation and restoring regularity.

Warnings

Choking

  • Taking this product without adequate fluid may cause it to swell and block your throat or esophagus and may cause choking. Do not take this product if you have difficulty in swallowing. If you experience chest pain, vomiting or difficulty in swallowing or breathing after taking this product, seek immediate medical attention

Allergy alert

  • This product may cause an allergic reaction in people sensitive to inhaled or ingested psyllium.

Ask a doctor before use if you have

  • a sudden change in bowel habits persisting for 2 weeks
  • have abdominal pain, nausea, or vomiting

Stop use and ask a doctor if

  • constipation lasts more than 7 days
  • rectal bleeding occurs

These may be signs of a serious condition

Keep out of reach of children

In case of accidental overdose, get medical help or contact a Poison Control Center right away.

Directions

Put one dose into an empty glass. Mix this product (child or adult dose) with at least 8 ounces (a full glass) of water or other fluid. Taking this product without enough liquid maycause choking. See choking warning. Stir briskly and drink promptly. If mixture thickens, add more liquid and stir.

adults & children
12 years & over
1 rounded TEASPOON in 8 oz of liquid
at the first sign of irregularity. Can be
taken up to 3 times daily. Generally
produces effect in 12-72 hours..
children under
12 years
consult a doctor.

Laxatives, including bulk fibers, may affect how well other
medicines work. If you are taking a prescription medicine by
mouth, take this product at least 2 hours before or 2 hours
after the prescribed medicine. As your body adjusts to
increased fiber intake, you may experience changes in bowel
habits or minor bloating. New Users: Start with 1 dose per
day; gradually increase to 3 doses per day as necessary.

Other information

  • each teaspoonful contains: potassium 30 mg, sodium 5 mg
  • Store a t room temperature.

Protect contents from humidity. Keep tightly closed.

Inactive Ingredients

Citric Acid and Maltodextrin.

Product Label

481

SUGAR FREE GERI-MUCIL 
psyllium powder, for solution
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:57896-481
Route of AdministrationORAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
PSYLLIUM HUSK (UNII: 0SHO53407G) (PSYLLIUM HUSK - UNII:0SHO53407G) PSYLLIUM HUSK3.4 g  in 100 g
Inactive Ingredients
Ingredient NameStrength
ANHYDROUS CITRIC ACID (UNII: XF417D3PSL)  
MALTODEXTRIN (UNII: 7CVR7L4A2D)  
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:57896-481-10283 g in 1 BOTTLE; Type 0: Not a Combination Product06/01/201411/30/2019
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph not finalpart33406/01/201411/30/2019
Labeler - GERI-CARE PHARMACEUTICAL CORP (611196254)
Registrant - GERI-CARE PHARMACEUTICAL CORP (611196254)

Revised: 4/2021
 
GERI-CARE PHARMACEUTICAL CORP